ANZCTR search results

This pilot study aims to test whether Montelukast and Gemfibrozil when added to CyBorD chemotherapy (Bortezomib Cyclophosphamide and Dexamethasone 28 day cycle) induces responses in patients not responding to this chemotherapy. Who is it for? You may be eligible to join this study if you are aged 18-80 years with progressive multiple myeloma after at least 8 weeks (two cycles) of treatment with a standard Bortezomib/Cyclophosphamide/Dexamethasone chemotherapy. Study details A total of 6 patients will be enrolled prior to a decision to expand or shut down the trial, depending on toxicity and response. Participants will receive further two cycles of CyBorD chemotherapy regimen with the addition of Montelukast. and Gemfibrozil.. Patients will be able to continue Montelukast and Gemfibrozil following completion if a response is observed depending on side effects The hypothesis is that Montelukast which is an extremely well tolerated medication used to treat Asthma in all age groups, will sensitize patient’s tumour to chemotherapy which was previously shown to be resistant to the same therapy.

During pregnancy, fetal growth restriction (FGR) is a recognised causal pathway to neurodevelopmental injury, which manifests, following birth, as cognitive and behavioural impairment as well as cerebral palsy. Currently, antenatal care is focused on detecting FGR and assessment of fetal wellbeing to guide timing of delivery. This approach seeks to maximize gestational age at birth to minimise the risks of prematurity, while delivering the fetus in time to minimise the likelihood of stillbirth. However, no therapies exist that can maximize fetal wellbeing in the setting of FGR and minimise the frequency of antenatally acquired brain injury. This double-blind RCT seeks to recruit n=332 women with FGR pregnancies to determine if antenatal maternal Melatonin administration can PROTECT the fetal brain and lead to improved neurodevelopmental outcomes.

The aim of this study is to identify and compare the efficacy and time-course of three different centrally demanding interventions (challenging balance; visuomotor; and externally-paced strength training) at inducing use-dependent neuroplasticity and driving functional improvements in community dwelling older adults aged 65 years and over. It is hypothesised that a single training session (independent of training type) will induce transient increases in corticospinal excitability and reductions in inhibition, and that older adults will experience use dependent neuroplasticity over the 12-week intervention period compared to a control group, It is further hypothesised that changes in the performance of lower-limb physical tasks will be dependent on the specific training group; and that neurological adaptations and changes to lower-limb task performance will decay after four weeks of no training. The results from this trial will provide insight into the potential for centrally demanding interventions to exploit the flexibility of the central nervous system's of older adults, and induce positive training related improvements in functional ability.

Relationship quality between community-dwelling people with dementia (PwD) and their family caregivers (FCG) is recognised as a major factor that influences health and wellbeing of both, and consequently impacts their ability to live together in the family home. The family home with familiar people and surroundings is recognised as the optimal care environment for PwD. Supporting PwD to remain in the family home also reduces care costs to individuals and society, and is recognised as a strategic priority by the Australian Government. The primary aim of this proposed randomised controlled trial is to determine whether therapeutic choir participation and supported home-based music engagement improve relationship quality between community-dwelling PwD and FCG. Secondary aims will examine whether the choir intervention is cost effective and can improve wellbeing and quality of life indicators for PwD and FCG. Key questions to be addressed by this randomised controlled trial ask whether therapeutic choir participation and home-based music engagement for community-dwelling people living with dementia and their family caregivers improve ratings for: • the primary outcome measuring relationship quality between PwD and FCG • and secondary outcomes measuring: 1) quality of life for PwD and FCG 2) depression for PwD and FCG 3) social connectedness for PwD and FCG 3) caregiver experience for FCG 4) observations of anxiety in PwD Using a single-blind, randomised controlled trial, 180 PwD + FCG dyads will be randomised to either 20 weekly choir sessions with home-based music program facilitated by a registered music therapist or a waitlisted control group. Eligible participants, recruited from 6 sites (4 metropolitan and 2 rural), will be community-dwelling people with a diagnosis of dementia and family caregivers who provide the majority of care in the home. Outcome measure questionnaires, collected by a blinded assessor, will be taken prior to the intervention (baseline), midpoint (week 11), and following completion of 20 choir sessions (week 21).

The study is a Phase 1, double-blind, randomized, placebo-controlled, first in human study of PRAX-330 to assess the safety, tolerability and pharmacokinetics of single ascending oral doses in healthy subjects.

Osteoporosis is a condition of greatly increased risk of low trauma fracture. Certain medications and exercises have been shown to increase bone density and decrease fracture risk. The additive effect of those two interventions might yield greater benefits as they have distinct individual effects. While osteoporosis medication has been shown to increase bone mass and reduce fracture, exercise improves bone, muscle and balance thereby reducing falls. This study will determine the independent and combined effect of exercise and bone medication on bone health in postmenopausal women at risk of osteoporosis. It will also compare the efficacy of two different exercise programs – a resistance and impact training program (HiRIT) and a Pilates exercise program.

Our proposal is to take brief interventions, proven to have a significant impact on young people's drinking, and apply them via mobile phone during actual drinking occasions. The intervention will consist of hourly mobile assessment and feedback. While on a night out, participants will receive hourly reminders to complete a very brief questionnaire through an online survey accessed via the SMS message. The questionnaire will involve hourly reports of their alcohol consumption and spending, where they are, and their mood. They will then receive an individually tailored feedback message via SMS in response to these data, which aims to stop or slow down their drinking, or avoid harmful consequences of drinking. The intervention will be delivered on drinking occasions on Friday and Saturday nights over a 6-week period. This study aims to determine the impact of a tailored brief intervention delivered by mobile phone on young people's high-risk alcohol consumption. We will use a randomised controlled trial design to generate high quality evidence of the impact of this intervention on single occasion risky drinking among young people.

Being overweight or obese increases the chance of a person developing chronic conditions such as diabetes and heart disease. This study aims to help these people find and use relevant health information to improve their diet, increase the amount of physical activity they do, and generally improve their health, thereby preventing the development of chronic disease. We are conducting this study in general practice because most Australians routinely visit their general practitioner (GP). We will be supporting GPs and practice nurses (PNs) to provide a smart phone/tablett app (SNAPP) that will allow each person to monitor aspects of their health like their weight, blood pressure and cholesterol and to track changes in these over time. Each person will receive individualised information, advice and support that will help them to set some achievable goals around lifestyle change. Each person will also be offered ten sessions of confidential telephone based counseling over a three month period. Nurses will guide this process and make assisted referrals for patients so they can access the help they want. Our research has shown a need for this type of program and previous results suggest that these programs can create lasting health benefits. This study aims to provide a non- judgemental approach and provide the assistance and advice needed to improve motivation, to stay on track and achieve individual goals. The aim of this study is to evaluate the implementation and effectiveness of a primary care based preventive care intervention. The intervention is tailored to the needs of, and develops the knowledge and skills of overweight or obese patients with low health literacy. The overarching research question is: Can an eHealth intervention tailored to low health literacy and targeted at overweight and obese individuals from general practice change: a) Patients general health literacy and eHealth literacy? b) Physiological risk factors? c) Lifestyle behaviours – smoking diet, alcohol and physical activity? d) The preventive care they receive in general practice from GPs and PNs and their adherence to planned care? PRIMARY HYPOTHESES: 1. Compared to those attending control general practices, overweight or obese patients who attend intervention practices will, at 6 and 12 months: a) Increase health literacy related to preventive care by 10% at 6 and 12 months b) Increased self-reported physical activity and daily fruit and vegetable intake by 10% at 6 and 12 months c) Decrease physiological risk factors by 7%: weight, blood pressure, at 12 months These changes will be greater for intervention group patients with lower than those with higher health literacy.

To investigate a psychobiological model of persistent pain in a mixed methods intervention study for women with persistent pain and a history of trauma, specifically: To investigate the potential of Bikram yoga as a mind-body integrative persistent pain therapy. That is, to quantitatively assess the efficacy of an 8 week intervention (3 classes per week) of instructor lead Bikram yoga classes, as compared to coached Adrenaline HIT group gym class, on pain levels and the associated underlying psychobiological mechanisms (dysregulated stress response outcomes). It is hypothesized that participants in the Bikram yoga group will show greater improvements in pain and stress dysregulation than the participants in the comparison Adrenaline HIT gym class group To quantitatively assess a psychobiological model of persistent pain, that is, the relationship between trauma history, dysregulated stress response outcomes and persistent pain levels where it is hypothesized that greater stress dysregulation will be associated with increased levels of persistent pain

Approval to pilot the new pharmacist role, collect baseline, post-intervention and demographic data from residents at control and intervention site. Staff and residents will be invited to participate in surveys or interviews to describe their experience with the new pharmacy practice role.